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FDA (Device enforcement)Recalled 2018-04-24closedclass ii

Medline Industries Inc: MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be

Is my product affected?

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not com

  • UPC 67016114502
  • UPC 67017014501
  • UPC 67017024502
  • UPC 67017054501

Check against the official notice below — it lists the full affected range.

What happened

Medline Industries Inc. has recalled approximately 23,150 units of MEDLINE O.R. Necessities Sterile Needle Counter (40 Count, Double Magnet/Foam Block with Blade Remover, reorder number NC100FBR) distributed worldwide, including across the United States, Canada, Saudi Arabia, Cayman Islands, and United Arab Emirates. The recalled product includes four specific lot numbers: 67016114502, 67017014501, 67017024502, and 67017054501.

The needle counters are being recalled because the packaging seals may experience seal creep, which could create gaps in the seals and compromise the sterility of the product. The source document does not specify a remedy or recommended action for consumers who have purchased this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

Details from the source

Reason for recall: The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters. Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates Quantity: 23150 units Lot/code info: Lot Numbers: 67016114502 67017014501 67017024502 67017054501

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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